1. Field of the Invention
The present invention relates to medical devices. More particularly, the present invention relates to mechanical implants acting as urinary sphincters in human beings having urinary incontinence.
2. Description of the Related Art
Currently available urinary sphincter devices are multi-component and cumbersome to place surgically in the human body. Multiple components need to be installed in different locations, and this is a time consuming and difficult process. Malfunctions in these devices are generally very difficult to detect and correct. They have very complicated components, making assembly, difficult and prone to complications. Those devices which use an inflatable ring to close off the urethra are prone to non-uniform inflation and resultant injury to the urethra. Others may not be effective for severe incontinence, or require access through the skin to operate. Some employ a magnetically operated valve requiring an external magnetic key to operate, the key being subject to loss or misplacement. Devices inserted directly into the urethra increase the likelihood of infection. Likely failure modes in many devices leave the urethra closed, which would result in the need of timely surgery to avoid bladder damage.
U.S. Pat. No. 3,810,259, issued May 14, 1974, to Summers is complicated and intrusive, and requires the use of magnetic keys which are subject to loss, or may be otherwise unavailable.
U.S. Pat. No. 5,643,194, issued Jul. 1, 1997, to Negre is similarly subject to loss of the very specialized magnetic key, and is primarily directed toward relief and drainage of fluid for treatment of hydrocephalus. This device could not be used to control urinary incontinence where a urethra remains intact.
U.S. Pat. No. 4,571,749, issued Feb. 25, 1986, and U.S. Pat. No. 4,784,660, issued Nov. 15, 1988, both to Fischell, describe inflatable cuffs located around the urethra. These devices are not uniformly inflated, resulting in likely damage to the urethra.
U.S. Pat. No. 4,118,805, issued Oct. 10, 1978, to Reimelds describes an artificial sphincter. It is a very complicated device, and thus can be subject to failure or maladjustment.
U.S. Pat. No. 6,074,341, issued Jun. 13, 2000, to Anderson et al. describes mechanically complicated embodiments of an artificial urethra sphincter. The mechanical operation of the occlusive apparatus appears to be difficult to operate through the skin. Other means of operation are complicated and subject to failure.
U.S. Pat. No. 6,095,969, issued Aug. 1, 2000, to Karram et al. describes an implantable device for controlling stress incontinence in female patients. This device is intended to control incontinence when a patient is coughing, etc. It would not be effective in more severe cases of incontinence.
U.S. Pat. No. 6,063,119, issued May 16, 2000, to Pintauro et al. describes a device for maintaining urinary incontinence. The device is inserted into the urethra and partially into the bladder. Such a device enhances the likelihood of infections and may potentially cause damage to the urethra inner wall or bladder.
None of the above inventions and patents, taken either singularly or in combination, is seen to describe the instant invention as claimed. Thus, an artificial urinary sphincter solving the aforementioned problems is desired.
The present invention provides a device for treatment of urinary incontinence in males and females which is a single component, mechanically uncomplicated, and hence less prone to failure. Malfunctions are easily fixed. Since it will be preassembled, it is easy to install through a single incision in one site.
The device incorporates an outer cuff having an inner cuff of interconnecting flexible fluid-containing portions. The outer cuff is installed. The device acts much as that of a retractable ball point pen, pushing on the overlapped portion to compress the fluid-containing portions so as to compress and shut the urethra when the button is first pushed, and then alternately relaxing pressure on the overlapped portion so as to release pressure on the urethra upon pushing the button the second time.
The fluid-containing portions are so designed that they will expand concentrically toward the urethra. Wires are wrapped around pulleys mounted on an inner portion of the push button base and one end of each wire anchored to the outer cuff in the vicinity of its overlapping outer portion, so as to move inward when the push button of the push button assembly is pushed. The wires wrap around the inner cuff of the artificial sphincter and are mounted at their other end to the outer cuff near its fixation opening so as to alternately contract and relax circumferential pressure on the inner cuff. This contracting action is coordinated with the inward pressure and relaxation of the overlapped outer cuff portion.
Accordingly, it is a principal object of the invention to provide an artificial urinary sphincter which is simple in design, easily used, and requires only one incision to implant.
It is another object of the invention to provide an artificial urinary sphincter as above providing uniform pressure around the urethra in a closed position.
It is a further object of the invention to provide an artificial urinary sphincter as above having an outer cuff surrounding an inner cuff, the inner cuff having interconnecting fluid filled compartments for providing uniform pressure around the urethra.
Still another object of the invention is to provide an artificial urinary sphincter having an assembly operable by a push button operated through the skin which alternately opens and closes the urinary sphincter.
It is an object of the invention to provide improved elements and arrangements thereof for the purposes described which is inexpensive, dependable and fully effective in accomplishing its intended purposes.
These and other objects of the present invention will become readily apparent upon further review of the following specification and drawings.